Agile raises $45M for contraceptive patch trials

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Agile Therapeutics pulled the wraps off a $45 million Series B preferred stock financing this morning--the company's first financing round since it landed $17.6 million in 2007. The funding will allow Agile to complete Phase III clinical development and file for marketing approval for its low-dose, weekly contraceptive patch AG200-15. The company will also advance AG1000, its progestin-only contraceptive patch for breastfeeding mothers, into Phase II clinical development. 

Thomas Rossi, CEO of the Princeton, NJ-based company, spent 20 years in Big Pharma, first working for SmithKline Beecham and later J&J, before he left to found SansRosa in 2003. That company was sold to CollaGenex just as Rossi took on the CEO spot at Agile. The tiny company's name fits it well. Agile, which has only five employees now but plans to double that as new trials get underway, relies heavily on just a handful of employees with deep experience. They make use of CRO and CMO help in order to carry off big projects while keeping their internal structure lean.

"Forty-five million is essentially what we set out to raise," Rossi tells FierceBiotech. He stressed how pleased he is with the quality of the investors, which include Investor Growth Capital and Care Capital, ProQuest Investments, Kaiser Permanente Ventures, and Novitas Capital. "The general conditions of the market don't help any company raise money, and we're one of the few that's done a significant raise from external investors."

There is only one contraceptive patch on the market. Johnson & Johnson's Ortho Evra was the most successful contraceptive launch ever, accounting for 12 percent of all sales in 2002. But in 2005 cardiac safety concerns arose due to its high estrogen dose. Though Ortho Evra's market share dropped as a result, Rossi tells FierceBiotech its strong debut demonstrates consumer's appetite for patch-based contraception.

Agile's version of the patch differs from Ortho Evra, which uses ethinyl estradiol and norelgestromin to prevent pregnancy. Rossi says Agile's AG200-15 uses estrogen in combination with levonorgestrel, the same hormones used in low-dose oral contraceptives. That hormone combination offers an improved safety profile over the existing option. "There's a great deal of epidemiology data that shows it's basically the safest contraceptive you can get," explains Rossi. The company also worked on its SKINFUSION technology to make sure the patch sticks well, looks good and feels good.

Agile expect to start AG200-15 enrollment by the end of this year, with AG1000 also moving into the clinic by the end of 2010. Agile has a number of additional preclinical programs underway that utilize its SKINFUSION patch technology. Though he wouldn't share details, the programs explore non-contraceptive uses of the patch in the women's health space. - Maureen Martino (twitter | email)